scholarly journals AB1099 EVALUATION OF DIFFERENT FLUORESCENCE-OPTICAL IMAGING (FOI) ASSESSMENT METHODS TO DIFFERENTIATE CLINICAL PSORIATIC ARTHRITIS FROM PSORIASIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1839.2-1839
Author(s):  
L. Haan ◽  
U. Henkemeier ◽  
A. C. Foldenauer ◽  
H. Burkhardt ◽  
F. Behrens ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Optical Imaging ◽  
Assessment Methods ◽  
Imaging Biomarkers ◽  
Stable Phase ◽  
Phase 2 ◽  
Research Support ◽  
Maximum Score ◽  
Fluorescence Optical Imaging ◽  
Significant Difference

Background:Psoriasis (Pso) is one of the most common chronic inflammatory skin diseases in Europe. Psoriatic arthritis (PsA) is closely associated to Pso whereas the skin manifestation appears usually years before PsA-related symptoms emerge. Up to 30% of Pso patients develop PsA, but there is no clear correlation between disease duration of Pso and PsA development. In early PsA, changes in synovial vascularisation combined with increased expression of proangiogenic factors appear first. Therefore, imaging biomarkers for detection of changes in vascularisation might be useful for early detection of musculoskeletal disease. Fluorescence-optical imaging (FOI) is an indocyanine green (ICG) tailored method to detect microvascular changes in the hands using ICG kinetics over 360 sec. Different methods for assessment of FOI are available. It has not yet been demonstrated to what extent these methods can be used to differentiate psoriasis from psoriasis arthritis.Objectives:To evaluate different reader dependent assessment methods to evaluate FOI in psoriasis and psoriatic arthritis.Methods:FOI data (clinical PsA n=137, PsO without PsA n=202) from an observational prospective multicentre trial in Germany was used for manual assessment of the films using two different published assessment methods:(1) FOI activity score (FOIAS) and (2) individual characteristics of ICG kinetics. For (1) FOIAS, the levels of signal enhancement were scored using a scoring system from 0 to 3 (0=no enhancement, 3=strong enhancement) per joint as well as an assessment of the summation picture. (2) Kinetics were determined by joint-related signal enhancements as well as by ICG related flow-on and flow-off behaviour. Time to the first appearance of the signal, the time to the maximum enhancement and the time to the end of the signal were determined.Results:By use of (1) FOIAS, the maximum score (overall signals of all joints assessed by FOIAS) showed a significant difference (p=0.0075) between PsA (mean 4.76) and PsO (mean 3.84). (2) Time to global maximum showed no significant difference (PsA mean 91.1 sec vs PsO 92.6 sec). Moreover, the mean time to maximum and clearance of ICG did not differ between the two diseases. The duration of the 3 phases of kinetic (phase 1: flow-in, phase 2: stable, phase 3: clearance) was 52.4 sec, 180.2 sec and 119.8 sec for PsA and 57.6 sec, 186.0 sec and 130.5 sec for PsO with an earlier phase 2 and 3 for PsA by trend. The most frequently affected joints in PsA (affected > 10%): PIP 3 right and PIP 5 right.Conclusion:FOI is a sensitive method to detect changes in microvascularisation in the hands. The use of the manual FOIAS is able to differentiate significantly between PsA and PsO patients by comparison of the sum of scores over all joints (maximum score). The assessment of ICG kinetics is limited to discriminate between musculoskeletal and joint disease, differentiation of diseases is only seen by trend. Both methods characterize disease states differently. A combination of both methods might be useful to increase the potential of manual assessment of FOI signals.Figure 1.Maximum sum score of FOIAS in PsO and PsA patients (p=0.0075 in two-sided t-test).Disclosure of Interests:Luis Haan: None declared, Ulf Henkemeier: None declared, Ann Christina Foldenauer: None declared, Harald Burkhardt Grant/research support from: Pfizer, Roche, Abbvie, Consultant of: Sanofi, Pfizer, Roche, Abbvie, Boehringer Ingelheim, UCB, Eli Lilly, Chugai, Bristol Myer Scripps, Janssen, and Novartis, Speakers bureau: Sanofi, Pfizer, Roche, Abbvie, Boehringer Ingelheim, UCB, Eli Lilly, Chugai, Bristol Myer Scripps, Janssen, and Novartis, Frank Behrens Grant/research support from: Pfizer, Janssen, Chugai, Celgene, Lilly and Roche, Consultant of: Pfizer, AbbVie, Sanofi, Lilly, Novartis, Genzyme, Boehringer, Janssen, MSD, Celgene, Roche and Chugai, Michaela Köhm Grant/research support from: Pfizer, Janssen, BMS, LEO, Consultant of: BMS, Pfizer, Speakers bureau: Pfizer, BMS, Janssen, Novartis

scholarly journals AB1111 PREDICTIVE VALUE OF FLUORESCENCE-OPTICAL IMAGING TECHNIQUE IN DETECTION OF PSORIATIC ARTHRITIS IN PSORIASIS PATIENTS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1845.1-1845
Author(s):  
M. Köhm ◽  
S. Ohrndorf ◽  
T. Rossmanith ◽  
M. Backhaus ◽  
G. R. Burmester ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Early Detection ◽  
Optical Imaging ◽  
Skin Diseases ◽  
Clinical Signs ◽  
Imaging Biomarkers ◽  
Clear Correlation ◽  
Research Support ◽  
Fluorescence Optical Imaging

Background:Psoriasis (Pso) is one of the most common chronic inflammatory skin diseases in Europe. Psoriatic arthritis (PsA) is closely associated to Pso whereas the skin manifestation appears usually years before PsA-related symptoms emerge. Up to 30% of Pso patients develop PsA, but there is no clear correlation between disease duration of Pso and PsA development. Therefore, biomarkers for its early detection are of major importance. In early PsA, changes in synovial vascularisation combined with increased expression of proangiogenic factors appear first. Therefore, imaging biomarkers for detection of changes in vascularisation might be useful for early detection of musculoskeletal disease. Fluorescence-optical imaging (FOI) is a new method to detect changes in microvascularisation of the hands.Objectives:To determine the number of positive PsA diagnosis within a 24 month follow-up period in PsO only patients with subclinical MSK-inflammation detected in FOI.Methods:Sensitivity of FOI for detection of subclinical signs of musculoskeletal inflammation as biomarker for early PsA was observed in a prospective, multicentre study (XCITING) including patients with dermatological confirmed skin psoriasis. 411 patients were included from dermatology care units across Germany without diagnosis of PsA but potential risk factors for its development (nail psoriasis and/or joint pain or swelling within the last 6 months). Clinical examination (CE; swollen (66) and tender (68) joint count, enthesitis, dactylitis assessment) and standardised ultrasound (US) assessment was performed by a qualified rheumatologist to assess musculoskeletal inflammation. FOI was performed additionally. Data was analysed in focus on increased vascularisation of musculoskeletal structures as inflammatory markers. In case of discrepant results (positive FOI and negative CE and US), MRI was performed to prove the findings. In case of MRI negativity, a follow-up period of 24-months was performed including FOI, CE, US and MRI assessment.Results:83 of the 411 patients of the cohort were negative in all assessments (Pso only), 136 of the 411 patients were classified as PsA by rheumatologic assessments. 119 patients showed subclinical signs of musculoskeletal inflammation in the central reading of FOI, whereas CE and US were negative. In 37,5% of those patients, subclinical inflammation was confirmed by MRI assessment. 22 patients of the cohort without MRI positivity were willing to be followed up until month 24. 5 (7.5%) patients developed a clinical PsA until month 24 whereas 7 (10.5%) patients converted to be FOI negative. In 5 patients an additional MRI examination was performed in which one patient showed positive signs for inflammation.Conclusion:FOI is an innovative method for measurement of changes in microvascularisation in the hands. 6/22 patients initial only positive in FOI (no clinical signs for PsA, negative US, negative MRI) developed either clinical evident PsA (n=5) or new inflammation in MRI (n=1) during follow-up of 24 months. Therefore, FOI positive signals in PsO patients increase the probability for PsA development.Figure 1.Flow Chart of the Follow-up period of the XCITING study.Disclosure of Interests:Michaela Köhm Grant/research support from: Pfizer, Janssen, BMS, LEO, Consultant of: BMS, Pfizer, Speakers bureau: Pfizer, BMS, Janssen, Novartis, Sarah Ohrndorf: None declared, Tanja Rossmanith Grant/research support from: Janssen, BMS, LEO, Pfizer, Marina Backhaus Grant/research support from: Pfizer, Gerd Rüdiger Burmester Consultant of: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma, Speakers bureau: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma, Siegfried Wassenberg: None declared, Benjamin Köhler Grant/research support from: Pfizer, Harald Burkhardt Grant/research support from: Pfizer, Roche, Abbvie, Consultant of: Sanofi, Pfizer, Roche, Abbvie, Boehringer Ingelheim, UCB, Eli Lilly, Chugai, Bristol Myer Scripps, Janssen, and Novartis, Speakers bureau: Sanofi, Pfizer, Roche, Abbvie, Boehringer Ingelheim, UCB, Eli Lilly, Chugai, Bristol Myer Scripps, Janssen, and Novartis, Frank Behrens Grant/research support from: Pfizer, Janssen, Chugai, Celgene, Lilly and Roche, Consultant of: Pfizer, AbbVie, Sanofi, Lilly, Novartis, Genzyme, Boehringer, Janssen, MSD, Celgene, Roche and Chugai

scholarly journals AB1138 ASSESSMENT OF FLUORESCENCE-OPTICAL IMAGING TECHNIQUE OF THE HANDS IN PSORIASIS AND PSORIATIC PATIENTS USING AN INNOVATIVE OBJECTIVE METHOD

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1859.2-1859
Author(s):  
L. Zerweck ◽  
U. Henkemeier ◽  
P. H. Nguyen ◽  
T. Rossmanith ◽  
A. Pippow ◽  
...  
Keyword(s):  
Time Series ◽  
Early Detection ◽  
Optical Imaging ◽  
Skin Diseases ◽  
Imaging Biomarkers ◽  
Research Support ◽  
Scoring Method ◽  
Inflammatory Skin Diseases ◽  
Data Set ◽  
Fluorescence Optical Imaging

Background:Psoriasis (Pso) is one of the most common chronic inflammatory skin diseases in Europe. Psoriatic arthritis (PsA) is closely associated to Pso whereas the skin manifestation appears usually years before PsA-related symptoms emerge. Up to 30% of Pso patients develop PsA, biomarkers for its early detection are of major importance. In early PsA, changes in synovial vascularisation appear first. Imaging biomarkers for detection of changes in vascularisation might be useful for early detection of musculoskeletal disease. Fluorescence-optical imaging (FOI) is a new method to detect changes in microvascularisation of the hands. Each collected data set of the FOI system contains 360 images representing a time progression of the indocyanine green (ICG) distribution.Objectives:To evaluate a reader-independent assessment method for evaluation of FOI in patients with PsO and PsA.Methods:A prospective study including patients with dermatological confirmed skin PsO was performed. 411 patients were included from German dermatology units without PsA diagnosis but potential risk for its development. Clinical examination (CE) was performed by a qualified rheumatologist. For a reader independent evaluation of the FOI images an objective joint-based scoring method was developed. For this method, the joint areas are defined by image segmentation and scored based on generated heatmaps. To calculate a heatmap indicating conspicuous joints from a data set containing 360 images, each pixel is converted to a time series containing 360 values. From this time series, three independent values (features) are extracted: amplitude, average value and maximal slope. Thus, each pixel is reduced to three different feature values. After the three features are determined for each pixel, k-means clustering is performed on each feature. The numbers of centroids (k) are set to 3, 5, 7 and 9. 12 heatmaps (3 features à 4 ks) are calculated, which results in 12 scores for each joint as well. The clusters are then sorted dependent on their centroid value and coloured accordingly to a predefined heatmap colour palette. To finally score each joint, the pixels in the segmented joint area and their assigned cluster are summed and normalized by the area’s amount of pixels and k.Results:271 of the patients were investigated by the newly developed method and compared with the CE scoring. 6426 joints were labeled as healthy whereas 1162 joints were either labeled as swollen, tender or both. The result over all investigated patients for k = 9 is summed in table 1. It is observable that every average and median healthy value is lower than the corresponding affected value.Table 1.Resulting scores for k = 9 for all 271 patients.Feature Statistic valueAmplitudeMeanSlopeHealthyAffectedHealthyAffectedHealthyAffectedAverage0.5030.5280.4860.5090.3950.414Median0.4960.5320.4820.5050.3890.415Conclusion:FOI is an innovative method that detects early changes in vascularization of the hands. So, this method can be useful in early detection of arthritis especially in risk populations such as PsO patients. The results of the objective scoring method show that a clear distinction between healthy and affected joints is possible with the average scores as well as the median values. However, if the range of the scores is considered, the overlap between healthy and affected is not neglectable. Thus, the current scoring system can be used as an indicator but not as a single classification marker. Nevertheless, the research at hand has shown the expected outcome and motivates further development on the heatmap approach.Disclosure of Interests:Lukas Zerweck: None declared, Ulf Henkemeier: None declared, Phuong-Ha Nguyen: None declared, Tanja Rossmanith Grant/research support from: Janssen, BMS, LEO, Pfizer, Andreas Pippow: None declared, Harald Burkhardt Grant/research support from: Pfizer, Roche, Abbvie, Consultant of: Sanofi, Pfizer, Roche, Abbvie, Boehringer Ingelheim, UCB, Eli Lilly, Chugai, Bristol Myer Scripps, Janssen, and Novartis, Speakers bureau: Sanofi, Pfizer, Roche, Abbvie, Boehringer Ingelheim, UCB, Eli Lilly, Chugai, Bristol Myer Scripps, Janssen, and Novartis, Frank Behrens Grant/research support from: Pfizer, Janssen, Chugai, Celgene, Lilly and Roche, Consultant of: Pfizer, AbbVie, Sanofi, Lilly, Novartis, Genzyme, Boehringer, Janssen, MSD, Celgene, Roche and Chugai, Michaela Köhm Grant/research support from: Pfizer, Janssen, BMS, LEO, Consultant of: BMS, Pfizer, Speakers bureau: Pfizer, BMS, Janssen, Novartis

scholarly journals POS0198 EFFICACY AND SAFETY OF DEUCRAVACITINIB, AN ORAL, SELECTIVE TYROSINE KINASE 2 INHIBITOR, IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS: RESULTS FROM A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 314.2-315
Author(s):  
P. J. Mease ◽  
A. Deodhar ◽  
D. Van der Heijde ◽  
F. Behrens ◽  
A. Kivitz ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Tyrosine Kinase ◽  
Phase 2 ◽  
Efficacy And Safety ◽  
Research Support ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Phase 2 Trial ◽  
Tyrosine Kinase 2 ◽  
Sf 36

Background:Tyrosine kinase 2 (TYK2) is an intracellular kinase that mediates signaling by key cytokines involved in psoriatic arthritis (PsA) and plaque psoriasis (PsO) pathogenesis. Deucravacitinib is a novel oral agent that selectively inhibits TYK2 via an allosteric mechanism by binding to the nonconserved regulatory domain of the kinase. A previous Phase 2 trial in PsO had demonstrated that deucravacitinib was efficacious and well tolerated, with no laboratory abnormalities observed.Objectives:To evaluate the efficacy and safety of deucravacitinib in active PsA.Methods:This is an ongoing, 1-year, randomized, double-blind, placebo (PBO)-controlled (initial 16 weeks), multiregional, Phase 2 trial (NCT03881059). Eligible patients had a PsA diagnosis for ≥6 months, met CASPAR criteria, and had active disease with ≥3 tender and ≥3 swollen joints, C-reactive protein ≥3 mg/L (ULN, 5 mg/L), and ≥1 psoriatic lesion (≥2 cm). Patients had failed or were intolerant to ≥1 nonsteroidal anti-inflammatory drug, corticosteroid, conventional synthetic disease-modifying antirheumatic drug (csDMARD), and/or 1 TNF inhibitor (TNFi; ≤30%). Patients were randomized 1:1:1 to deucravacitinib 6 mg once daily (QD) or 12 mg QD, or PBO. The primary endpoint was achievement of ACR 20 response at Week 16. Additional endpoints included the proportion of patients achieving ACR 50/70 response, Health Assessment Questionnaire-Disability Index (HAQ-DI) response (≥0.35 improvement from baseline), enthesitis resolution (Leeds Index score of 0), minimal disease activity, change from baseline in SF-36 physical component score (SF-36 PCS) and mental component score (SF-36 MCS), Psoriasis Area and Severity Index (PASI) 75 response, adverse events (AEs), and laboratory parameters.Results:Of 203 patients randomized, 180 (89%) completed 16 weeks of treatment (deucravacitinib 6 mg QD, 63/70 [90%]; deucravacitinib 12 mg QD, 59/67 [88%]; PBO, 58/66 [88%]). Demographic and baseline disease characteristics were similar across groups. Mean age was 49.8 years, 51% of patients were female, median PsA duration was 4.5 years, 66% of patients used csDMARDs at baseline and throughout the study, and 15% had used a TNFi. This study met its primary endpoint, with deucravacitinib 6 mg and 12 mg QD demonstrating significantly higher ACR 20 responses versus PBO at Week 16 (Figure 1). Additional endpoints were also met with deucravacitinib versus PBO (Figure 1). Adjusted mean changes from baseline in SF-36 PCS and SF-36 MCS at Week 16, respectively, were significantly higher in the deucravacitinib 6 mg QD group (5.6 vs 2.3, P=0.0062; 3.6 vs 0.7, P=0.0211) and 12 mg QD group (5.8 vs 2.3, P=0.0042; 3.5 vs 0.7, P=0.0263) compared with PBO. PASI 75 responses were also significantly higher in the deucravacitinib groups (P≤0.0136 vs PBO). The most common AEs in the deucravacitinib 6 mg/12 mg/PBO groups, respectively, during the 16-week treatment period were nasopharyngitis (5.7%/17.9%/7.6%), sinusitis (0%/7.5%/0%), headache (7.1%/1.5%/4.5%), and rash (4.3%/6.0%/0%). No serious AEs, herpes zoster infections, opportunistic infections, or thrombotic events were reported in deucravacitinib-treated patients during this period. Additionally, no significant changes from baseline in hematologic parameters (lymphocytes, neutrophils, platelets, and hemoglobin) or serum lipids were observed with deucravacitinib treatment.Conclusion:Deucravacitinib was efficacious versus PBO over 16 weeks in patients with active PsA. Treatment was generally well tolerated and the safety and laboratory parameter profile of deucravacitinib was consistent with that observed in an earlier Phase 2 PsO trial.Acknowledgements:This study was sponsored by Bristol Myers Squibb. Professional medical writing assistance was provided by Peloton Advantage, LLC, an OPEN Health company, and funded by Bristol Myers Squibb.Disclosure of Interests:Philip J Mease Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN Pharma, UCB, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN Pharma, UCB, Atul Deodhar Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Glaxo Smith & Kline, Janssen, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Eli Lilly, Glaxo Smith & Kline, Novartis, Pfizer, UCB, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma, Frank Behrens Consultant of: Pfizer, AbbVie, Sanofi, Lilly, Novartis, Genzyme, Boehringer, Janssen, MSD, Celgene, Roche, Chugai, Bristol Myers Squibb, UCB Pharma, Grant/research support from: Pfizer, Janssen, Chugai, Celgene, Roche, Alan Kivitz Shareholder of: Pfizer, Sanofi, GlaxoSmithKline, Gilead Sciences, Inc., Novartis, Paid Consultant: AbbVie, Boehringer Ingelheim, Flexion, Janssen, Pfizer, Sanofi, Regeneron, SUN Pharma Advanced Research, Gilead Sciences, Inc., Speakers bureau: Celgene, Merck, Lilly, Novartis, Pfizer, Sanofi, Genzyme, Flexion, AbbVie, Jonghyeon Kim Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Shalabh Singhal Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Miroslawa Nowak Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Subhashis Banerjee Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb

scholarly journals SAT0398 PERSISTENCE OF USTEKINUMAB (UST) OR TNF INHIBITOR (TNFI) TREATMENT IN PSORIATIC ARTHRITIS (PsA): INSIGHTS FROM THE LARGE, PROSPECTIVE, MULTINATIONAL, REAL-WORLD PsABio COHORT

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1149-1150
Author(s):  
L. Gossec ◽  
S. Siebert ◽  
P. Bergmans ◽  
K. De Vlam ◽  
E. Gremese ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Real World ◽  
Treatment Effect ◽  
Cox Model ◽  
Tnf Inhibitor ◽  
Skin Involvement ◽  
Research Support ◽  
Treatment Persistence ◽  
Kaplan Meier ◽  
Significant Difference

Background:Several biologic DMARDs (bDMARDs) exist for PsA, TNFi and UST being the earliest on European markets. When bDMARDs are insufficiently effective, later-line bDMARDs typically have shorter persistence. Treatment persistence reflects a mix of effectiveness and adverse events (AEs), and persistence data are limited in PsA.Objectives:Comparative analysis of 1-year persistence of UST and TNFi within the prospective PsABio cohort.Methods:PsABio is an observational, multinational study of PsA patients (pts) treated with 1st to 3rd line UST or TNFi at their rheumatologist’s discretion.1Treatment persistence (up to 15 months of follow-up) was defined as time between start of first bDMARD treatment in PsABio, and either stop or switch to another bDMARD, or withdrawal.Persistence of UST and TNFi is shown by Kaplan-Meier curves and compared using Cox regression analysis, with propensity score (PS) to adjust for baseline imbalanced demographic and disease-related covariates (age, sex, bDMARD line, BMI, Clinical Disease Activity index for PSoriatic Arthritis [cDAPSA], 12-item PsA Impact of Disease [PsAID-12], Fibromyalgia Rapid Screening Tool [FiRST] score, co-treatments with MTX, NSAIDs, glucocorticoids, cardiovascular/metabolic comorbidities, dactylitis, enthesitis and body surface area [BSA]). Factors including concomitant MTX use and skin involvement: <3%, 3–10% and >10%, were added to the Cox model to investigate their impact on the PS-adjusted treatment effect.Results:Of 438 and 455 pts who started UST and TNF, respectively, 121 (28%) and 134 (29%) stopped or switched treatment before Month 15, with differences (as expected) according to treatment line (Fig. 1a, b). Reasons for stop/switch were related to safety/AEs in 12% (UST) and 28% (TNFi), and effectiveness (joints, nails or skin) in 77% (UST) and 69% (TNFi) of pts.The observed mean time on drug was 397 days for UST and 385 days for TNFi pts (1st line 410/397 days, 2nd 390/382 days, 3rd 381/338 days). Fig. 1b shows similar persistence for all drugs and treatment lines, except for lower persistence in TNFi 3rd line vs 1st/2nd. In PS-adjusted Cox analysis, no statistically significant difference between UST and TNFi persistence was seen; hazard ratio (HR; 95% CI) for stop/switch bDMARD (UST vs TNFi) was 0.82 (0.60, 1.13). In the model, bDMARD monotherapy (without MTX) and extensive skin involvement (BSA >10%), showed significantly better persistence for UST (HR 0.61 [0.42, 0.90] and 0.41 [0.19, 0.89] respectively; unadjusted Kaplan-Meier graphs shown in Fig. 1c, d). MTX co-therapy and low BSA did not affect the PS-adjusted treatment effect. Other factors added to the PS-adjusted Cox model did not show significant effects.Conclusion:In this real-world PsA cohort undergoing bDMARD treatment, persistence was generally comparable for UST and TNFi, but some clinical situations led to better drug persistence with UST compared to TNFi – particularly monotherapy, more extensive skin involvement, and in 3rd-line treatment. Our data emphasise the importance of skin involvement for pts with PsA.References:[1]Gossec L, et al.Ann Rheum Dis. 2018;77(suppl 2):Abstract AB0928Acknowledgments:This study was funded by Janssen.Disclosure of Interests:Laure Gossec Grant/research support from: Lilly, Mylan, Pfizer, Sandoz, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB, Stefan Siebert Grant/research support from: BMS, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB, Consultant of: AbbVie, Boehringer Ingelheim, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Celgene, Janssen, Novartis, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Kurt de Vlam Consultant of: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – consultant, Speakers bureau: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – speakers bureau and honoraria, Elisa Gremese Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Tatiana Korotaeva Grant/research support from: Pfizer, Consultant of: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Speakers bureau: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Wim Noel Employee of: Janssen Pharmaceuticals NV, Michael T Nurmohamed Grant/research support from: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Consultant of: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Speakers bureau: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Petros Sfikakis Grant/research support from: Grant/research support from Abvie, Novartis, MSD, Actelion, Amgen, Pfizer, Janssen Pharmaceutical, UCB, Elke Theander Employee of: Janssen-Cilag Sweden AB, Josef S. Smolen Grant/research support from: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Consultant of: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi

scholarly journals Detection of subclinical skin manifestation in patients with psoriasis and psoriatic arthritis by fluorescence optical imaging

2020 ◽  
Author(s):  
Angelique Schmidt ◽  
Anne-Marie Glimm ◽  
Ida Kristin Haugen ◽  
Paula Hoff ◽  
Gabriela Schmittat ◽  
...  
Keyword(s):  
Risk Factors ◽  
Body Weight ◽  
Psoriatic Arthritis ◽  
Optical Imaging ◽  
Correct Diagnosis ◽  
Skin Inflammation ◽  
The Body ◽  
Healthy Controls ◽  
Healthy Individuals ◽  
Fluorescence Optical Imaging

Abstract Objectives: To investigate the frequency of subclinical skin inflammation in both hands by fluorescence optical imaging (FOI) in patients with psoriasis/psoriatic arthritis (Pso/PsA) vs. rheumatoid arthritis (RA) and healthy individuals, and to correlate these findings with cardiovascular (CV) risk factors.Patients and Methods: The FOI scans were analyzed retrospectively to detect clinically invisible skin enhancement (0-3 scale) in both hands without relationship to underlying joints or blood vessels. We further characterized the FOI patterns and sorted the scans into groups based on the assumed diagnosis (Pso/PsA, RA and healthy controls), which was compared with the physician’s diagnosis. Furthermore, the associations between CV risk factors and imaging findings were investigated by regression analyses.Results: We included FOI scans of patients with Pso/PsA (n=80), RA (n=78) and healthy controls (n=25). Subclinical skin enhancement on the back of their hands was more common in Pso/PsA (72.5%) than in RA patients (20.5%) and healthy individuals (28.0%) (p<0.001). Based on the FOI pattern, the majority of patients with Pso/PsA (72.5%), RA (76.9%) and healthy controls (68.0%) were classified correctly using the physician-based diagnosis as reference (overall agreement of 74%, kappa=0.57). No CV risk factors except body weight (kg) was associated with subclinical skin enhancement (OR 1.04, 95% CI 1.02-1.06; p<0.001). Conclusion: Subclinical subdermal skin inflammation was common in Pso/PsA patients using FOI. Based on the FOI pattern, most patients with Pso/PsA and were classified with the correct diagnosis. We demonstrated an important influence of the body weight on our FOI results. FOI may be a helpful novel tool to study microcirculation in rheumatic diseases with skin involvement.

scholarly journals POS1401 ASSESSMENT OF INTERREADER RELIABILITY IN SCORING PATIENTS WITH HAND OSTEOARTHRITIS AND PSORIATIC ARTHRITIS BY FLUORESCENCE OPTICAL IMAGING

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 983.2-983
Author(s):  
B. Drude ◽  
Ø. Maugesten ◽  
S. G. Werner ◽  
G. R. Burmester ◽  
J. Berger ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Optical Imaging ◽  
Phase 1 ◽  
Hand Osteoarthritis ◽  
Scoring Method ◽  
Cohen’S Kappa ◽  
Fluorescence Optical Imaging ◽  
Cohen's Kappa ◽  
Kappa Value ◽  
Pip Joint

Background:Fluorescence Optical Imaging (FOI) utilises the fluorophore indocyanine green (ICG) to reflect enhanced microcirculation in hand and finger joints due to inflammation.Objectives:We wanted to assess the interreader reliability of FOI enhancement in patients with hand osteoarthritis (OA) and psoriatic arthritis (PsA). Furthermore, predefined typical morphologic patterns were included to determine the ability of FOI to discriminate between both diagnoses.Methods:An atlas with example images of grade 0-3 in different joint groups and typical morphologic patterns (‘streaky signals’[1], ‘green/blue nail sign’[2], ‘Werner sign’[3,4], and ‘Bishop’s crozier sign’) of PsA and hand OA was created. Two readers scored all joints in both hands (30 in total) of 20 cases with hand OA and PsA. The cases were randomly mixed and both readers were blinded to diagnosis. Each joint was rated on a semiquantitative scale from 0 to 3 in five different images (PrimaVista Mode (PVM), phase 1, 2 (first and middle image), and 3) during the FOI sequence according to the scoring method FOIAS (fluorescence optical imaging activity score)[1,3]. Interreader reliability on scoring joint enhancement was calculated using linear weighted Cohen’s kappa (κ). Agreement on diagnosis (hand OA vs. PsA) and different morphologic patterns was assessed by calculating (regular) Cohen’s kappa.Results:Overall agreement on scoring joint enhancement (all phases) was substantial (κ = 0.75), with greatest consensus in phase 2 first (κ = 0.75) and lowest agreement in phase 1 (κ = 0.46). Reliability varied in different joint groups (wrist, MCP, (P)IP, DIP), with almost perfect overall agreement on PIP joint affection (κ = 0.81), substantial agreement on wrist (κ = 0.69) and DIP joint affection (κ = 0.63), and moderate agreement on MCP joint affection (κ = 0.49) across all phases. Consensus on morphologic patterns showed overall fair agreement (κ = 0.37) with a similar kappa value on the ability to discriminate between both diagnoses (κ = 0.3).Conclusion:Joint enhancement in FOI can be reliably assessed using a predefined scoring method. The ability of FOI to differentiate between hand OA and PsA seems to be limited. Clearer definition and more training might be needed to better agree on morphologic patterns in FOI.References:[1] Glimm AM, Werner SG, Burmester GR, et al. Ann Rheum Dis. 2016 Mar;75(3):566-570[2] Wiemann O, Werner SG, Langer HE, et al. J Dtsch Dermatol Ges. 2019 Feb;17(2):138-148[3] Werner SG, Langer HE, Ohrndorf S, et al. Ann Rheum Dis. 2012 Apr;71(4):504-510[4] Zeidler H 2019. Fluoreszenzoptische Bildgebung. In: Zeidler H, Michel BA. Differenzialdiagnose rheumatischer Erkrankungen 5. Aufl. Springer, Heidelberg, S. 88-89Disclosure of Interests:Benedict Drude: None declared, Øystein Maugesten: None declared, Stephanie Gabriele Werner: None declared, Gerd Rüdiger Burmester: None declared, Jörn Berger Employee of: Xiralite GmbH, Ida K. Haugen: None declared, Sarah Ohrndorf: None declared

scholarly journals SAT0407 FOLLOW-UP EXAMINATION FOR THE DETECTION OF POTENTIAL PSORIATIC ARTHRITIS BY FLUORESCENCE OPTICAL IMAGING – IN COMPARISON TO MUSCULOSKELETAL ULTRASOUND

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1155.2-1156
Author(s):  
J. Büttner ◽  
A. M. Glimm ◽  
G. Kokolakis ◽  
M. Erdmann-Keding ◽  
G. R. Burmester ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Optical Imaging ◽  
Dropout Rate ◽  
Musculoskeletal Ultrasound ◽  
Group Iii ◽  
Fluorescence Optical Imaging ◽  
Group I ◽  
Group Ii ◽  
Inflammatory Changes

Background:Up to 30% of all plaque-type psoriasis patients develop psoriatic arthritis (PsA) (1). Early diagnosis of PsA can be difficult due to its heterogenous manifestation and the lack of disease- specific biomarkers, but it is crucial for disease outcome. Recently, our group has shown that fluorescence optical imaging (FOI) can be a helpful diagnostic tool for early PsA diagnosis since it can differentiate between patients with confirmed PsA and suspected PsA (2).Objectives:To follow-up patients by FOI with confirmed and suspected PsA with special focus on the group of patients in which PsA could be confirmed between baseline and follow-up – and to compare with the findings of musculoskeletal ultrasound (US).Methods:Patients included in our previous study (1) were re-evaluated by FOI of both hands in a standardized manner using the predefined phases 1-3 (p1-p3) and the PrimaVistaMode (PVM). US in greyscale (GS) and power Doppler (PD) were performed of the clinically dominant hand (for tenderness and/or swelling) in the dorsal and palmar view at wrist, MCP, PIP and DIP 2-5 joint levels for synovitis and tenosynovitis.Subsequently, a comparison of the findings in the affected joints was performed using US as the reference method. Furthermore, AUC was calculated to show the extent to which a new joint inflammation was associated with a change in diagnosis.Results:Of the 60 patients initially examined (1), 30 patients (dropout rate 50%) were followed-up approximately 3 years later. The patients were newly divided into 3 groups: Diagnosed PsA (n=14, Group I), still suspected PsA, (n=6, Group II) and in-between diagnosed PsA (n=10, Group III). Patients with a change in the diagnosis from suspected to diagnosed PsA (Group III) showed a significantly increased prevalence of joints with pathological findings in FOI (46% at baseline, 88% at follow-up; p=0.046), with an unchanged joint distribution pattern, i.e. with a dominant involvement of the DIP joints. Compared to baseline, patients of group III were three times more common to show enrichment in p3 in FOI at follow-up (1.7% vs. 7.0%; p=n.s.). Newly detected pathologic joints by FOI (PVM, p2) and US at follow-up were positively associated with the change of diagnosis from suspected PsA to confirmed PsA (FOI: AUC 0.78; GSUS: AUC 0.77).Using US in greyscale as reference, inflammatory changes in the joints were diagnosed in all 3 cohorts by means of FOI in P1 and P3 with high specificity (Group III: 90.6%, Group II: 97.5%, Group I: 94.2%) and low sensitivity (Group III: 24.4%, Group II: 20.3%, Group I: 19.8%).Conclusion:FOI appears to be helpful to differentiate between acute and chronic disease stages. Furthermore, it is specific for detecting inflammatory changes in the joints of the hands in PsA – in comparison to US. FOI could thereby become a helpful tool as a “dermatological-screening” method to select psoriasis patients with indication for further rheumatological evaluation.References:[1]Zachariae H. Prevalence of Joint Disease in Patients with Psoriasis: Implications for therapy. Am J Clin Dermatol. 2003;4(7):441–447. Review.[2]Erdmann-Keding M, Ohrndorf S, Werner SG, et al. Fluorescence optical imaging for the detection of potential psoriatic arthritis in comparison to musculoskeletal ultrasound. J Dtsch Dermatol Ges. 2019;17(9):913-921.Disclosure of Interests:Juliane Büttner: None declared, Anne-Marie Glimm: None declared, Georgios Kokolakis: None declared, Magdalena Erdmann-Keding: None declared, Gerd Rüdiger Burmester Consultant of: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma, Speakers bureau: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma, Jens Klotsche: None declared, Sarah Ohrndorf: None declared

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